Frequency Therapeutics — Hearing Loss Regeneration

[Tweedleman]

That's still pretty good advice, don't you think? From a hearing loss perspective anyway. I generally respect Cliff's opinion.

I think it is insofar as people that genuinely need hearing aids don't hold out and suffer in isolation, and increased risk of dementia, etc.

But the videos shortsightedness with respect to the 10 dB threshold improvement in 4 patients, and the fact that it was only a small safety dosage in the first place, is unfairly dismissive of the drug's potential.

He comes off as too conclusive and heavyhanded about it not being "the cure for hearing loss." Especially considering we are still waiting for the real efficacy results.

 

[serendipity1996]

I like this guy and respect his channel but he neglects the fact that it was only a small safety doseage administered and that there were actually 4 patients if I recall correctly that did have a 10 dB threshold improvement @ 8 kHz. And they didn't report what was likely OHC growth in the UHF's.

Hoping @FGG can ready a good response to him

Yeah I felt like it wasn't really fair to make statements about the efficacy given they were primarily testing for safety at that stage. Found it a bit odd that that was overlooked. Still, seems encouraging that at least audiologists are aware of these regenerative treatments that are in the pipeline.

 

[mrbrightside614]

@mrbrightside614 @FGG @HootOwl @Hazel @Markku

Hey all! I've been lurking on this thread with a watchful eye for a couple of months now.

Thank you for all that you do.

Seriously, one of the few good things my hearing loss/tinnitus has given me is a great sense of admiration and sympathy for those of us who endure these burdens! Especially those of you who put in what is obviously hours per day to simply help and inform others.

I believe this would give any sensible person hope for humanity if they didn't have any before, and I cannot state my fondness of you enough.

I've pitched the below questions through the survey for the upcoming podcast (totally missed that link before) but am reposting to get some discussion going if possible:

What can those of us who are aware of FX-322 do to ensure we get the treatment as soon as possible?

Elaboration incoming:

Once this drug is approved to hit the market (as I believe it will) and the press gets a whiff of it, there is bound to be a media storm and a presumably large backlog of appointments at every clinic that offers Intratympanic injections.

We know that for the clinical trials, participants had to have an audiogram going back at least 6 months to show that hearing loss was stable.

Would it be a good idea for those of us who haven't had a professional audiogram to get one done - could demonstrably stable hearing loss end up being a prerequisite in order to receive the actual treatment?

In addition, while we don't know exactly when it's hitting the market, it has crossed my mind to schedule an appointment with a qualified ENT as soon as the drug is approved.

For example, my provider lets me email doctors about issues before meeting them; I could potentially inform my ENT of choice that I want to make an appointment in advance to receive the FX-322 treatment, in turn 'reserving' my treatment in wake of the incoming frenzy.

If I could be so bold, I believe that all of us who care enough to follow the developments on FX-322 want our injections ASAP.

Due to our acute awareness, we'll likely know when it's approved for the market before the vast majority of the public does: even if it's only by a few hours or days.

At the risk of sounding selfish, I'd like to leverage that headstart in order to get the treatment without standing in line behind the 30 million or so other American hearing loss sufferers, if at all possible.

Again, thanks for all that you do, I am truly inspired by your kind actions. I'm looking forward to the upcoming podcast, and intend on becoming a patron!

This is a concern of mine as well. It's going to be a hard ask because a lot of tinnitus sufferers "have no identifiable hearing loss" and this drug is first and foremost a hearing loss drug. Even if they show significant efficacy for tinnitus, it is probably not going to be covered by your insurance. I have no idea if the medical community will treat this on a first-come:first-served basis or will treat those of greater need with higher priority.

I'd say what you can do is book appointments ahead of time with your ENT as information emerges regarding Frequency's release timeline. You can always move the appointment back as new information emerges. Make sure it's with an ENT who is informed on the drug and is confident in their ability to deliver treatment, although I'm not sure how purchase/stocking will play out.

I firmly believe the people who've managed to take the time to be informed on this drug should be rewarded in receiving more timely treatment. I'll try to find a way to weave this into a follow-up.

 

[serendipity1996]

This is a concern of mine as well. It's going to be a hard ask because a lot of tinnitus sufferers "have no identifiable hearing loss" and this drug is first and foremost a hearing loss drug. Even if they show significant efficacy for tinnitus, it is probably not going to be covered by your insurance. I have no idea if the medical community will treat this on a first-come:first-served basis or will treat those of greater need with higher priority.

I'd say what you can do is book appointments ahead of time with your ENT as information emerges regarding Frequency's release timeline. You can always move the appointment back as new information emerges. Make sure it's with an ENT who is informed on the drug and is confident in their ability to deliver treatment, although I'm not sure how purchase/stocking will play out.

I firmly believe the people who've managed to take the time to be informed on this drug should be rewarded in receiving more timely treatment. I'll try to find a way to weave this into a follow-up.

To add to this, I can't really imagine this sort of thing being readily offered to patients with tinnitus with 'no identifiable hearing loss' on a standard audiogram in the UK under the NHS. If that were the case, I'd just seek private treatment or fly out to the States lol so I can get it ASAP.

 

[all to gain]

This is a concern of mine as well. It's going to be a hard ask because a lot of tinnitus sufferers "have no identifiable hearing loss" and this drug is first and foremost a hearing loss drug. Even if they show significant efficacy for tinnitus, it is probably not going to be covered by your insurance. I have no idea if the medical community will treat this on a first-come:first-served basis or will treat those of greater need with higher priority.

I'd say what you can do is book appointments ahead of time with your ENT as information emerges regarding Frequency's release timeline. You can always move the appointment back as new information emerges. Make sure it's with an ENT who is informed on the drug and is confident in their ability to deliver treatment, although I'm not sure how purchase/stocking will play out.

I firmly believe the people who've managed to take the time to be informed on this drug should be rewarded in receiving more timely treatment. I'll try to find a way to weave this into a follow-up.

The demand for this drug is probably going to push the price up for those who want/have to go privately, i.e. not only the price of the drug, but also the price of seeing an ENT. Like someone else said, specialised clinics are going to pop up everywhere once this hits the market, which might, hopefully, make the market more competitive and bring the price down eventually.

Let's hope this drug comes out in both Japan and the US at the same time to give folks a bit more choice.

In the UK there is little hope that this will be offered on the NHS for either tinnitus or hearing loss. They will keep with good old hearing aids for as long as possible.

 

[AtlasFainted]

This is a concern of mine as well. It's going to be a hard ask because a lot of tinnitus sufferers "have no identifiable hearing loss" and this drug is first and foremost a hearing loss drug. Even if they show significant efficacy for tinnitus, it is probably not going to be covered by your insurance. I have no idea if the medical community will treat this on a first-come:first-served basis or will treat those of greater need with higher priority.

I'd say what you can do is book appointments ahead of time with your ENT as information emerges regarding Frequency's release timeline. You can always move the appointment back as new information emerges. Make sure it's with an ENT who is informed on the drug and is confident in their ability to deliver treatment, although I'm not sure how purchase/stocking will play out.

I firmly believe the people who've managed to take the time to be informed on this drug should be rewarded in receiving more timely treatment. I'll try to find a way to weave this into a follow-up.

I agree. Scheduling an appointment months ahead of time and pushing it back as needed sounds like a good plan. I'm planning on saving a few thousand dollars this year in anticipation of FX-322, and borrowing the rest from family if needed.

My fingers aren't crossed for insurance; I can imagine this treatment will have most providers sweating when you consider the scale of it. They will do anything they can to keep from paying out.

I suspect that though the drug my be approved by the FDA for one use (hearing loss), doctors will use their discretion to administer it as needed for issues such as tinnitus. We've seen this happen in the past with other drugs; what really matters in my opinion is that FX-322 simply gets to market.

That being said, I haven't gotten a professional high frequency audiogram yet (sounds like it is a good idea to do that soon), but through playing around with various tone generators, it's pretty obvious that my right ear stops picking up noise at about the 10kHz mark.

My left ear seems to hear perfectly all the way to 18kHz, which is above average for my age, but I have tinnitus in both ears - the left ear's tinnitus just tends to be higher in pitch.

 

[AtlasFainted]

The demand for this drug is probably going to push the price up for those who want/have to go privately, i.e. not only the price of the drug, but also the price of seeing an ENT. Like someone else said, specialised clinics are going to pop up everywhere once this hits the market, which might, hopefully, make the market more competitive and bring the price down eventually.

Let's hope this drug comes out in both Japan and the US at the same time to give folks a bit more choice.

In the UK there is little hope that this will be offered on the NHS for either tinnitus or hearing loss. They will keep with good old hearing aids for as long as possible.

While there will be a giant demand, that demand will also be spread across a giant amount of people.

If they mark up prices too high, they will actually lose money overall because they will be excluding the millions of people who would purchase the treatment at a lower cost.

Because of this, I'm not overly concerned about the cost of FX-322 being too asinine. I'm sure they realize the scope of what they are looking at and don't want to alienate 90% of their consumer base.

I'm only speculating, but I don't think that the treatment will cost more than 10k for both ears, at the most.

 

[all to gain]

While there will be a giant demand, that demand will also be spread across a giant amount of people.

If they mark up prices too high, they will actually lose money over all because they will be excluding the millions of people who would purchase the treatment at a lower cost.

Because of this, I'm not overly concerned about the cost of FX-322 being too asinine. I'm sure they realize the scope of what they are looking at and don't want to alienate 90% of their consumer base.

I'm only speculating, but I don't think that the treatment will cost more than 10k for both ears, at the most.

I hope you are right. Of course, multiple courses of treatment may be needed. There is so much still to be determined, but I'm going to have to save like you... I may have to sell my body

 

[AtlasFainted]

I hope you are right. Of course, multiple courses of treatment may be needed. There is so much still to be determined, but I'm going to have to save like you... I may have to sell my body

Yeah there is a ton still to be determined, and I tend to lean on the optimistic side just a little.

I tend to be a visual thinker and when I think about FX-322, I imagine likely spending thousands of dollars.

However I also imagine having hearing that is virtually perfect (maybe even up to 20kHz in both ears) and completely unafflicted by tinnitus or ear pain (which I get mildly for a few seconds a day).

To me that would be worth it! Between this and LASIK, science is making me into a million dollar man!

 

[F-u-T]

Still, seems encouraging that at least audiologists are aware of these regenerative treatments that are in the pipeline.

The audiologist I went to for CBT was also well aware of FX-322. I got the feeling he was worried a drug like this could really hurt his business.

 

[Jaysterk]

For those of you that have taken Prednisone a few times in the past (like myself), do you guys fear that it has depleted the necessary support cells that FX-322 needs in order to function? Has it stopped anyone from taking Prednisone in the future?

 

[Lucifer]

The audiologist I went to for CBT was also well aware of FX-322. I got the feeling he was worried a drug like this could really hurt his business.

Of course they are worried about their business. What are they even suppose to do when hearing regeneration medicine come out. They will probably have to shut down or invest in something else.

It's a sad thing when they have that type of ideology of making profit rather than treating the customer. That shows they only care about their business rather than their customers.

 

[Diesel]

As far as FX-322 "hurting" business for ENTs or Audiologists... that's complete BS. In the case of nearly any breakthrough product, the market grows. In the short-term, the vintage business goes into decline (probably CBT, hearing aids), but replaced with a robust new market (regeneration). Consider when digital music distribution (iPods) began replacing CDs in the early 2000s.

So, if anything, it will increase.

In a future where partial or all ranges of hearing can be restored with FX-322, patients will still need to come back to their Audiologist at least annually for a checkup to see how their restored hearing is fairing. From there, any spectrum of treatments could take place. Some may need another dose annually to repair new damage/normal wear occurring after their original FX-322 treatment. Others may need nothing, but to pay for the annual check-up. As treatment improves, some may need to come back for the "2.0" or "3.0" treatment; assuming FX-322 doesn't work for 100% of all cases.

 

[JohnK]

For those of you that have taken Prednisone a few times in the past (like myself), do you guys fear that it has depleted the necessary support cells that FX-322 needs in order to function? Has it stopped anyone from taking Prednisone in the future?

Prednisone is just a corticosteroid. It stops inflammation. It has all sorts of side effects but I don't think going after support cells is one of them.

 

[AtlasFainted]

As far as FX-322 "hurting" business for ENTs or Audiologists... that's complete BS. In the case of nearly any breakthrough product, the market grows. In the short-term, the vintage business goes into decline (probably CBT, hearing aids), but replaced with a robust new market (regeneration). Consider when digital music distribution (iPods) began replacing CDs in the early 2000s.

So, if anything, it will increase.

In a future where partial or all ranges of hearing can be restored with FX-322, patients will still need to come back to their Audiologist at least annually for a checkup to see how their restored hearing is fairing. From there, any spectrum of treatments could take place. Some may need another dose annually to repair new damage/normal wear occurring after their original FX-322 treatment. Others may need nothing, but to pay for the annual check-up. As treatment improves, some may need to come back for the "2.0" or "3.0" treatment; assuming FX-322 doesn't work for 100% of all cases.

Yeah people fear change. Overall though as you said it seems like they would simply need to become providers of the new technology (FX-322).

I personally probably wouldn't go for an annual checkup, but I'm sure there's a huge hidden market of people who have hearing loss but don't like the idea of getting hearing aids. As you said, the market would expand.

 

[Tweedleman]

I really do hope specialized, LASIK style hearing regen clinics pop up, right from the beginning. I wont wait for audiologists to adapt, I don't need their say.

Look at how many of them have their heads up last centurys ass. You say the words cochlear synaptopathy to them and they look at you like you're speaking gibberish. "Oh, you must mean central audio processing disorder. You don't have that. You're hearing perfectly normally." "Liberman who?" It's absolutely wild that we have like 3 synaptopathy drugs already in clinical trials before the impairment itself even enters the audiology textbooks. We have researchers on the cusp of treating problems doctors still don't know exist.

Are many audiologists at all trained to conduct intraympanic injections? If I'm going to have a specialized clinician or ENT inject me, would I not just return to THEM to monitor hearing progress? I mean, they can conduct simple hearing tests, too. Why bother with an audiologist if amplification isn't part of the equation in your treatment?

If and when regeneration becomes a reality, I think the entire landscape will change. Perhaps not in the beginning, but the more regenerative medicine we have to combat the array of hearing problems, the role of the audiologist will have to evolve accordingly. Or, their slice of the pie will eventually shrink if all they have to offer is what they do now (hearing aids).

 

[Pink Noise]

To add to this, I can't really imagine this sort of thing being readily offered to patients with tinnitus with 'no identifiable hearing loss' on a standard audiogram in the UK under the NHS. If that were the case, I'd just seek private treatment or fly out to the States lol so I can get it ASAP.

I think flying out to the United States is the only way to get timely treatment. I'm sure it has to go through NICE (NHS procurement) first who will most likely do their own testing.

Spoke to my audiologist about FX-322 on Friday and she said it's probably going to be expensive and take time to be onboarded via the NHS.

 

[all to gain]

I think flying out to the United States is the only way to get timely treatment. I'm sure it has to go through NICE (NHS procurement) first who will most likely do their own testing.

Spoke to my audiologist about FX-322 on Friday and she said it's probably going to be expensive and take time to be onboarded via the NHS.

@serendipity1996

Maybe members from the UK could find a place to get FX-322 in the US and fly out together. We could ask for a group booking discount I'm being serious...

 

[BBakkers]

@serendipity1996

Maybe members from the UK could find a place to get FX-322 in the US and fly out together. We could ask for a group booking discount I'm being serious...

I'm doing the same thing. When the time is ripe I will organize a trip for around 10 people I know who have tinnitus.

 

[all to gain]

I'm doing the same thing. When the time is ripe I will organize a trip for around 10 people I know who have tinnitus.

Yeah, I think the costs could be kept down. When I said 'group booking' I meant for the actual treatment, but maybe for things like hotels and maybe even flights a group booking could also be made.

 

[F-u-T]

Are many audiologists at all trained to conduct intraympanic injections? If I'm going to have a specialized clinician or ENT inject me, would I not just return to THEM to monitor hearing progress?

Audiologists are not Medical Doctors MD so they cannot perform surgery (IT Injections) or prescribe medication.

 

[F-u-T]

As far as FX-322 "hurting" business for ENTs or Audiologists... that's complete BS.

Of course FX-322 won't hurt business for ENTs. ENTs are the only way you will be able to get an IT injection of FX-322. ENTs will be thrilled to finally have a drug and surgery procedure they can offer for tinnitus and hearing loss. They will profit most from FX-322.

Audiologists who only sell hearing aids or CBT as their main business revenue I would argue will be affected.

 

[Pink Noise]

Question: If I need multi doses would that mean hanging around the US or travelling again?

 

[Tweedleman]

Question: If I need multi doses would that mean hanging around the US or travelling again?

Good question. I don't think we know how quickly the drug works its magic yet. Maybe there's a timeline from P1? Given how slow the ears heal on their own, my guess is at least a few months to see the full effects of a doseage.

I'm wondering if doseage impacts the speed of regeneration. As well as how much of the goop we can safely soak into our cochlea in one dose. Will there be a safe limit, or a point at which a certain maximum is all that is necessary?

This is where I can see the need for specialized clinics, to work with the patient and package a tailored treatment plan for the individual based on hearing loss.

 

[FGG]

Question: If I need multi doses would that mean hanging around the US or travelling again?

Likely imo. But maybe we can start a thread when the time comes for Americans who are willing to host non-Americans for treatment.

 

[Chriscom]

I like this guy and respect his channel but he neglects the fact that it was only a small safety dosage administered and that there were actually 4 patients if I recall correctly who did have a 10 dB threshold improvement @ 8 kHz. And they didn't report what was likely OHC growth in the UHF's.

Hoping @FGG can ready a good response to him

Late responding to this but I pretty much agree. He's a great resource but this isn't as complete as I'd expected. On the other hand he doesn't like to overpromise things either, so I think this reflects that tendency.

What I got from the video: this is exciting but still buy hearing aids and don't wait for it.

At this exact moment, that's not bad advice.

 

[serendipity1996]

Quite worried about the outlook for the phase 2 trials given the current COVID-19 situation... anybody have any reassurance?

 

[ajc]

Quite worried about the outlook for the phase 2 trials given the current COVID-19 situation... anybody have any reassurance?

The trials will likely be late due to coronavirus. People are not being recruited anymore and existing participants are staying home.

 

[FGG]

Quite worried about the outlook for the phase 2 trials given the current COVID-19 situation... anybody have any reassurance?

Sensorion just announced a COVID-19 related delay in their trial. Unfortunately, i imagine other biotechs doing the same very soon.

 

[mrbrightside614]

Quite worried about the outlook for the phase 2 trials given the current COVID-19 situation... anybody have any reassurance?

Honestly I don't think anyone has any idea. We need a vaccine before anyone can predictably move forward with their lives/careers.